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Title: Fluoxetine Does Not Decrease Symptoms in Depressed Teens With Substance-Use Disorder: Presented at AACAP
URL: http://www.pslgroup.com/dg/21688E.htm
Doctor's Guide
October 31, 2007


By Maria Bishop

BOSTON, MA -- October 31, 2007 -- Fluoxetine is no different from placebo in reducing the symptoms of depression in teens who have also have a substance-use disorder, according to research presented here at the 54th Annual Meeting of the American Academy of Child & Adolescent Psychiatry (AACAP).

Robert L. Findling, MD, Director of both the Child and Adolescent Psychiatry Center and Discovery & Wellness Center for Children, University Hospitals Case Medical Center, Cleveland, Ohio, United States, presented the findings of a placebo-controlled, 8-week study.

Dr. Findling and colleagues enrolled 34 outpatients aged 12 to 17 and diagnosed with depression. All subjects met Diagnostic and Statistical Manual Revision IV criteria for a major depressive disorder (MDD) or dysthymic disorder, and all have symptoms of depression of at least moderate severity. They all also had a comorbid substance-related disorder.

Most subjects were white and male (both 78%).

Subjects received either 10 mg fluoxetine (n = 18) or matching placebo (n = 16) for the first 4 weeks of treatment. At week 4, subjects in the treatment arm could increase their dose to 20 mg, while placebo subjects matched.

Comparison of the primary outcome via mixture model analysis demonstrated no treatment difference in mean change in Children's Depression Rating Scale-Revised (CDRS-R) total score (P =.74). In the random effects regression model, there was no significant treatment by visit interaction (P =.14), indicating no difference between treatment groups in mean change in CDRS-R over time.

There was also no greater decrease in substance use in the treatment group than in the placebo group. Rates of positive urine drug screens did not differ between groups (P = 0.65). Substance use disorders in this trial were cannabis (56%), polysubstance (39%) and alcohol (11%).

Dr. Findling noted that three placebo patients and six treatment-arm patients discontinued the study; three in the treatment arm discontinued due to lack of efficacy.

Fluoxetine is approved for the treatment of paediatric depression, and is the third most prescribed antidepressant in the United States.

This study was primarily supported by the American Foundation for Suicide Prevention and the St. Luke's Foundation of Cleveland, Ohio. Study medications were provided, in part, by Lilly.


[Presentation title: Fluoxetine Versus Placebo Treatment of Depression and Co-Morbid Substance Abuse: Abstract B5]

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